Efficacy Study of Mirtazapine to Treat Interferon-related Depression During Antiviral Therapy for Hepatitis C

March 19, 2020 updated by: Won Kim, Seoul National University Boramae Hospital

Phase 4 Open-labeled Study to Compare the Anti-depressive Efficacy Between Mirtazapine and Psychotherapy for Patients With Interferon-related Depression During Antiviral Therapy for Hepatitis C

The purpose of this study is to evaluate the anti-depressive efficacy of mirtazapine in depression induced by peginterferon alpha-2a and ribavirin treatment in Korean patients with chronic hepatitis C.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Depression is a common serious adverse event (30%-50%) during the interferon treatment for chronic hepatitis C. Adequate control of depressive symptoms might enable to adhere to antiviral therapy and lead to the favorable prognosis for patients with chronic hepatitis C.

Mirtazapine is an effective antidepressant for depressive mood as well as insomnia and anxiety. Mirtazapine has also relatively lower drug-drug interactions, which are important for patients with hepatic dysfunction.

In this study, the investigators are going to perform an 8-week, randomized, open label trial comparing anti-depressive efficacy between mirtazapine and supportive psychotherapy in depression induced by peginterferon alpha-2a and ribavirin treatment in Korean patients with chronic hepatitis C.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Major depressive episode diagnosed with Diagnostic and Statistical Manual Diploma in Social Medicine-IV (DSM-IV)
  • Hamilton Depression Scale (HAMD-17) ≥ 14

Exclusion Criteria:

  • Any other axis I primary diagnoses except major depressive disorder
  • Having serious adverse events or hypersensitivity to mirtazapine
  • Having major depressive disorder prior to the first injection of interferon

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mirtazapine
Drug: Mirtazapine
Mirtazapine will be administered at baseline, 1-week, 2-week, 4-week, 6-week, and 8-week, dosing between 7.5mg/day and 45mg/day, in patients with interferon induced depression.
Other Names:
  • Remeron
Other: Supportive psychotherapy
Supportive psychotherapy will be given by a specialized psychiatrist.
Other: Supportive psychotherapy
Supportive psychotherapy will be administered at baseline, 1-week, 2-week, 4-week, 6-week, and 8-week in patients with interferon induced depression.
Other Names:
  • psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Hamilton Depression Rating Scale (HAMD)-17 at 8 weeks
Time Frame: Baseline and 8-week of andi-depressive treatment
depression change
Baseline and 8-week of andi-depressive treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in quality of life at 8 weeks
Time Frame: Baseline and 8-week of andi-depressive treatment
Psychometric assessment of quality of life using The Brief Form of the World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF) and Liver Disease Quality of Life (LDQOL)
Baseline and 8-week of andi-depressive treatment
Genetic polymorphism
Time Frame: Baseline
Determination of genetic factors (single nucleotide polymorphism) as predictors of clinical responses to mirtazapine in interferon-induced depression.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Boramae Hospital

Investigators

  • Principal Investigator: Won Kim, MD, PhD, Seoul Metropolitan Government Boramae Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2011

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

October 31, 2011

First Submitted That Met QC Criteria

November 2, 2011

First Posted (Estimate)

November 6, 2011

Study Record Updates

Last Update Posted (Actual)

March 20, 2020

Last Update Submitted That Met QC Criteria

March 19, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-2011-130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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